Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.
Checked against the public recordLast updated Oct 19, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Amgen
- Interventions being studied
- Drug: Carboplatin; Drug: Paclitaxel; Drug: ABP 215; Drug: Bevacizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) * Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 Exclusion Criteria: * Small cell lung cancer (SCLC) or mixed SCLC and NSCLC * Central nervous system (CNS) metastases * Malignancy other than NSCLC * Palliative radiotherapy for bone lesions inside the thorax * Prior radiotherapy of bone marrow * Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * Life expectancy \< 6 months * Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment * Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment * Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products * Other inclusion/exclusion criteria may apply
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteBismarck, North Dakota
- Research SiteFremantle, Western Australia
- Research SiteVeliko Tarnovo, Veliko Tarnovo
- Research SiteRousse
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 19, 2017. Always confirm current availability with the study team.